Xylocaine 4% Preservative Free

NDA 10417, held by Fresenius Kabi USA. Lidocaine Hydrochloride.

As of Nov 13, 2026, NDA 10417 (Xylocaine 4% Preservative Free), held by Fresenius Kabi USA, was first approved by FDA on May 7, 1959, with 24 approved supplements and 0 published complete response letters.

First approved: May 7, 1959
Review: Priority
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
May 7, 1959	Original applicationNew dosage form · Priority review	Approved	None posted

Products

2 strengths and forms


Xylocaine 4% Preservative Free4% · injectable;injection	Lidocaine Hydrochloride	DiscontinuedReference drug
Xylocaine 4% Preservative Free4% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;topical	Lidocaine Hydrochloride	DiscontinuedReference drug

All 25 submissions, including labeling and manufacturing supplements


Mar 28, 2013	Supplement 32Manufacturing · Priority review	Approved	None posted
Mar 28, 2013	Supplement 31Labeling · Standard review	Approved	None posted
Feb 19, 2010	Supplement 27Labeling	Approved	Letter Label
Mar 12, 1999	Supplement 22Labeling · Standard review	Approved	None posted
Sep 13, 1996	Supplement 19Manufacturing · Priority review	Approved	None posted
Mar 11, 1996	Supplement 21Manufacturing · Priority review	Approved	None posted
Jul 11, 1995	Supplement 20Manufacturing · Priority review	Approved	None posted
Nov 22, 1994	Supplement 18Manufacturing · Priority review	Approved	None posted
Feb 18, 1993	Supplement 17Manufacturing · Priority review	Approved	None posted
Jul 11, 1989	Supplement 16Manufacturing · Priority review	Approved	None posted
Sep 16, 1987	Supplement 15Manufacturing · Priority review	Approved	None posted
Mar 25, 1985	Supplement 11Labeling	Approved	None posted
Jun 20, 1984	Supplement 14Manufacturing · Priority review	Approved	None posted
Aug 9, 1982	Supplement 10Labeling	Approved	None posted
Aug 9, 1982	Supplement 9Manufacturing · Priority review	Approved	None posted
Jun 28, 1982	Supplement 13Manufacturing · Priority review	Approved	None posted
Mar 25, 1982	Supplement 12Manufacturing · Priority review	Approved	None posted
Dec 4, 1980	Supplement 7Labeling	Approved	None posted
Dec 4, 1980	Supplement 6Manufacturing · Priority review	Approved	None posted
Nov 3, 1980	Supplement 8Labeling	Approved	None posted
Nov 3, 1980	Supplement 5Manufacturing · Priority review	Approved	None posted
Jun 13, 1980	Supplement 3Labeling	Approved	None posted
Aug 29, 1979	Supplement 4Labeling	Approved	None posted
Feb 1, 1973	Supplement 2Labeling	Approved	None posted
May 7, 1959	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 10417
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters